Melissa LaFreniere  |  April 27, 2015

Category: Legal News

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fdaThe Food and Drug Administration is under investigation after a recent Risperdal lawsuit alleges the government agency failed to listen to citizen concerns regarding use of the anti-psychotic drug in children regardless of numerous complaints.

The plaintiff is a Pennsylvania law firm that has filed hundreds of lawsuits on behalf of children alleging serious Risperdal side effects. The Risperdal lawsuit filed against the FDA alleges that hundreds of pediatric patients have been injured after using Risperdal by developing serious side effects including male breast growth, or gynecomastia.

Risperdal drug manufacturers Johnson & Johnson are also named in the lawsuit for holding onto confidential complaint documents and not releasing them to the FDA.

This Risperdal lawsuit is one of many recently filed that claim Johnson & Johnson failed to warn teens and young adults about the possibility of developing man boobs. According to similar Risperdal lawsuits, male plaintiffs ended up with breasts measuring as large as a 38D cup size.

Other defendants named in the Risperdal lawsuit include the Department of Health and Human Services, HHS Secretary Sylvia Matthews Burwell, and FDA Commissioner Dr. Margaret A. Hamburg.

The plaintiff is not seeking any financial retribution in this Risperdal lawsuit but rather requesting that Risperdal either be banned for pediatric use or seriously cautioned against on the drug’s warning label.

Risperdal Breast Tissue Growth

Risperdal was approved by the FDA in 1993 and started being used for the treatment of psycological and neurological problems including schizophrenia, mania, bipolar disorder and even autism. Although it was marketed and sold to both adults and children, Riseperdal was not approved to treat pediatric patients until 2006.

Recent studies show that Risperdal side effects may include gynecomastia (man boobs), especially when taken by young men. The medication produces an increased level of prolactin, which is a hormone that regulates breast growth in women. In males, an excessive amount of breast hormones reportedly leads to man boobs.

More and more doctors are using the anti-psychotic drug to treat a variety of other conditions including ADD and ADHD. As Risperdal becomes more widely prescribed, there are concerns about the lack of gynecomastia warning risks associated with the medication especially since the side effects may last long after an individual has stopped taking the drug.

Studies show that while there may not be serious physical dangers associated with developing gynecomastia, the psychosocial impact is severe.

Risperdal Lawsuit

The Risperdal lawsuit filed in a Pennsylvania federal court claims that after receiving confidential accusations about the medication, the the law firm filed a citizen complaint with the FDA. According to the lawsuit, the Pennsylvania law firm requested that the FDA gather the complaints directly or allow the law firm to be released from confidentiality agreements in order to release the documents. The request was denied by the FDA and according to the plaintiff so was the petition to warn users of the gynecomastia risk on the drug label.

This Risperdal lawsuit is one of thousands pending against drug manufacturers Johnson & Johnson and their subsidiary Janssen Pharmaceuticals. Most Risperdal lawsuits allege the company is responsible for negligence and failure to warn about possible Risperdal complications.

Johnson & Johnson continues to defend their product despite settling numerous Risperdal lawsuits out of court. The company claims that breast development is part of puberty and normal for boys.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Risperdal attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Risperdal class action lawsuit is best for you. [In general, Risperdal lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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If you or your son took Risperdal between the ages of 10 and 18 years old and suffered gynecomastia (male breast growth), male breast pain, nipple pain, or nipple discharge, you may be entitled to compensation. See if you qualify by submitting your information below for a free and confidential case review.

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